Evaluation of the F&P Mask, US, 2026
Key facts
- Where
- St Louis, United StatesSee the site
Where in United States
- Clayton Sleep InstituteSt Louis, United StatesContact: Matthew UhlesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Fisher and Paykel Healthcare
- Trial code
- NCT07826429
- Record updated
- 16 October 2026
- Original description
This clinical investigation is designed to validate and confirm the overall performance, safety, usability, reliability, and acceptability of the F\&P PAP mask in a home environment.Read full original descriptionShow less
Evaluation of the F&P PAP Mask, US, 2026
This clinical investigation is designed to validate and confirm the overall performance, safety, usability, reliability, and acceptability of the F\&P PAP mask in a home environment.
Inclusion: Are ≥22 years of age; Weigh ≥66 pounds; Have been prescribed PAP/NIV therapy by a physician; Are an existing PAP/NIV therapy mask user with ≥3 months of use prior to enrolment in the clinical investigation*; Are compliant with PAP/NIV therapy for ≥4 hours per night for ≥70% of nights for a 14-day period within 30 days prior to enrolment in the clinical investigation; Are fluent in spoken and written English; Possess the capacity to provide informed consent.
Exclusion: Are intolerant to PAP/NIV therapy; Are required to use PAP/NIV therapy for >12 hours per day or for extensive periods, not including sleep or naps; Use a PAP/NIV therapy device for the delivery of medicines, except supplemental O2; Use a PAP/NIV therapy device that does not possess data recording capabilities to capture AHI and a numerical indicator of leak that is accessible to the clinical investigation site; Possess, or suffer from, anatomical or physiological conditions which make PAP/NIV therapy inappropriate; Have a history of light-induced seizures (for optional anthropometric scan only); Are trying to get pregnant, are pregnant, or think they may be pregnant; Have an IPAP pressure of >30 cmH2O if on BPAP.